BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIBP PATIENT HOSE, 3 METERS, MALE QUICK CONNECT

    MDR report key: 7977078 · Received October 18, 2018

    Report

    Report Number
    7977078
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Date of Event
    June 15, 2018
    Report Date
    September 28, 2018
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    MASIMO NIBP TUBING PART NUMBER 91-0028-69 CONNECTOR BECOMES DISLODGED FROM THE TUBING WHEN TRYING TO DISCONNECT TUBING FROM THE BP CUFF. ONCE THE CONNECTOR IS PULLED OUT, THE CONNECTION IS LOOSE AND THERE IS AIR LEAKAGE, AND THE CUFF BECOMES EASILY DISCONNECTED. THIS MAKES TAKING THE BP UNRELIABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819910 NIBP PATIENT HOSE, 3 METERS, MALE QUICK CONNECT SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN MASIMO CORPORATION A18C927

    Patients

    Seq Age Sex Outcome Treatment
    1